FDA 2016 Decision and History

After a decade of consumer and environmental advocacy and with many manufacturers taking the hazardous, antibacterial ingredient triclosan out of their soap and cosmetic products, the U.S. Food and Drug Administration (FDA) announced on September 2, 2016 that it will no longer allow 19 specific active ingredients, including triclosan and triclocarban, to be used in soap products, citing potential health risks and bacterial esistance. For years, groups have called on FDA and its counterpart, the U.S. Environmental Protection Agency (EPA) (which regulates non-cosmetic products with triclosan) to ban triclosan from consumer products, and FDA’s action comes after Beyond Pesticides and Food and Water Watch petitioned both agencies to ban triclosan and triclocarban from consumer products. FDA has given product manufacturers one year after publication of the final order to remove triclosan from its products. After that, products containing these ingredients will be misbranded unless they are authorized under a new drug application.

In 2013, FDA announced that was requiring manufacturers to prove that their antibacterial soaps were safe and more effective than soap and water, including providing the agency with data from clinical studies to demonstrate that the products were more efficacious than non-antibacterial products. However, manufacturers did not provide data establishing their products’ safety and effectiveness for the 19 ingredients FDA. For three ingredients –benzalkonium chloride, benzethonium chloride and chloroxylenol– FDA has postponed, for one year, a final decision, citing the need for additional data. Most importantly, FDA concludes that washing with plain soap and water is “one of the most important steps consumers can take to avoid getting sick and prevent spreading germs to others.”

Triclosan (5-chloro-2-(2,4-dichlorophenoxy)phenol) is an antibacterial and antifungal compound that is widely used as an antibacterial agent, bactericide, disinfectant, and fungicide. It is regulated by both FDA and the Environmental Protection Agency (EPA), though the bulk of triclosan-containing products are under FDA jurisdiction. Triclosan uses that fall under FDA’s jurisdiction include hand soaps, toothpastes, deodorants, laundry detergents, fabric softeners, facial tissues, antiseptics for wound care, and medical devices. Triclosan use in textiles and plastics is regulated by EPA and these products are not allowed to make any public health claims. Triclosan is currently being reviewed by EPA with a decision expected in 2020.

Triclosan’s cousin, triclocarban, is also an antibacterial chemical with a structure and function similar to triclosan. While triclosan is widespread in a wide array of consumer products, triclocarban has been mostly used in soaps, and thus regulated by FDA. Both commonly contaminate waterways, are associated with negative health and environmental impacts, have no added consumer health value.

On Safety

FDA states that new information suggests that widespread antibacterial use could have an impact on the development of bacterial resistance, and that long-term exposures to these antibacterial substances are higher than the agency first thought. The safety data required from manufacturers include nonclinical and human pharmacokinetic studies, developmental and reproductive toxicity studies, and carcinogenicity studies; data to characterize potential hormonal effects; and data to evaluate the development of bacterial resistance. FDA finds that the available data “are insufficient to establish the safety of long-term, daily repeated exposure to these active ingredients used in consumer wash products.”

Over the last decade, a number of studies have verified the occurrence of triclosan resistance among a variety of microorganisms. Evidence is mounting that links the use of triclosan-containing products with the promotion of bacteria resistant to antibiotic medications and antibacterial products. The European Commission’s Scientific Committee on Consumer Safety (SCCS) found in its opinion published in 2010 that, “ Low concentrations of triclosan can trigger the expression of resistance and cross-resistance mechanisms in bacteria in vitro. . . [which] warrants further investigation.”1

Resistance effects have been shown at low, bacteriostatic and sub-biocidal levels.2 Triclosan-resistant strains of Escherichia coli and Salmonella enterica have already been identified.3,4,5 Of major concern is the possibility that triclosan resistance may contribute to reduced susceptibility to clinically important antimicrobials, due to either cross-resistance or co-resistance mechanisms.

Previous studies have documented triclosan as having a high body burden, due to its widespread use. Being fat soluble, triclosan accumulates, and has been found in fatty tissue, breast milk, and blood.6,7,8 One study found triclosan in pregnant women sampled at levels higher than non-pregnant women and even the national average.9 Studies have linked triclosan to endocrine disruption and a variety of endpoints associated with hormonal interference. One study finds that triclosan may promote breast cancer by exhibiting estrogenic activity altering the expression of genes related to cancer progression.10 Additionally, the structural similarity of triclosan to thyroid hormones has raised concerns about adverse effects on thyroid homeostasis. A study involving Wistar rats found that although triclosan does not alter androgen-dependent tissue weights or onset of preputial separation, it does significantly impact thyroid hormone concentrations, specifically suppressing total serum thyroxine (T4) concentrations in male juvenile rats.11 Triclosan can also impair the ability of isolated heart muscle cells and skeletal muscle fibers to contract. Specifically, in the presence of triclosan, normal communication between two proteins that function as calcium channels became impaired, causing skeletal and cardiac muscle failure.12

On Efficacy

FDA also required manufacturers to show with studies a direct clinical benefit (a reduction of infection) greater than what could be obtained with a non-antibacterial soap and water in reducing infection. Subsequently, the agency found that the data provided was “insufficient to demonstrate that there is any additional benefit” when compared to non-antibacterial soap and water.

Triclosan’s impact on the consumer market has been aided by a false public perception that antimicrobial products are best to protect and safeguard against potential harmful bacteria. Studies conclude, however, that antibacterial soaps show no health benefits over plain soaps. One study looking at consumer bacterial soaps concludes that, for consumer use, triclosan has no added health benefits over soap and water. The researchers conclude, “The results of our review call into question the marketing of soaps containing triclosan as a product providing efficacy beyond the use of plain soap in the community setting. . .Current findings warrant actions by the FDA for evaluating consumer product advertising claims.”13

Congressional Concerns

Over the past few years, triclosan has garnered intense media and congressional attention. In 2010,U.S. Representative Ed Markey (D-MA) submitted letters of concern to both EPA and FDA. In the letter to EPA, Rep. Markey questions whether the agency is reviewing existing data on triclosan, and if EPA has made a decision about further regulating the chemical. Rep. Markey also asked if the agency examined the impact of triclosan on wildlife, and whether it plans to evaluate the chemicals under the Endocrine Disruptor Screening Program. Additionally, Rep. Louise M. Slaughter (D-NY) and two colleagues asked FDA to ban triclosan in 2010 due to the hazards that the chemical poses, including antibiotic resistance and potential health problems leading to higher health care costs.

In FDA’s response, the agency acknowledged that soaps containing triclosan offer no additional benefit over regular soap and water. FDA stated, “Existing data raise valid concerns about the [health] effects of repetitive daily human exposure to these antiseptic ingredients.” It announced plans to address the use of triclosan in cosmetics or other products. FDA also expressed concern about the development of antibiotic resistance from using antibacterial products and about triclosan’s potential long-term health effects.

Public Pressure for Action

Due to growing public pressure, several major manufacturers had already quietly reformulated their products to exclude triclosan, while others have announced that they will no longer use the chemical. Johnson and Johnson and Proctor and Gamble have both publicly stated they will phase out triclosan from their line of products, while Colgate-Palmolive has reformulated its popular line of liquid soaps. There has also been local action around the procurement of triclosan. For instance, Minnesota in 2013 announced that all state-run agencies would stop purchasing products that contain triclosan.

Since 2004, Beyond Pesticides has worked to bring public attention to the dangers surrounding the proliferate use of triclosan in consumer goods. A petition submitted to both FDA and EPA by Beyond Pesticides in 2010 calls for the ban on triclosan based on the unnecessary health and environmental risks involved with its use, given the availability of safer alternatives. Now that growing public awareness and the evolving market shift away from triclosan, the time is now for a complete federal ban on this unnecessary chemical. FDA should expand its ban on triclosan in hand soaps to all over-the-counter products, including toothpaste. It is critically important that EPA now step up to do the same for all the consumer product uses that it regulates.

Alternatives

1. Wash hands frequently and thoroughly. Regular soaps lower the surface tension of water, and thus wash away unwanted bacteria. Lather hands for at least 10 to 15 seconds and then rinse of in warm water. It is important to wash hands often, especially when handling food, before eating, after going to the bathroom, and when someone in your house is sick.

2. Wash surfaces that come in contact with food with a detergent and water.

3. Wash children’s hands and toys regularly to prevent infection.

4. If washing with soap and water is not possible, use alcohol-based sanitizers.

Triclosan Timeline

1960s The first patent for triclosan was issued in 1966 to the chemical company Ciba.

1972 By 1972 triclosan, although initially restricted to medical settings, makes its way into the consumer market.

1974 FDA first proposed rulemaking to establish a monograph for over the counter (OTC) topical antimicrobial drug products, including triclosan. The rulemaking has not been finalized.

**Over the next several decades triclosan is allowed to permeate the consumer market in deodorants, toys, plastics and textiles, soaps, toothpastes, kitchen utensils, etc, with essentially no government oversight**

1997

In 1997, EPA acted to prevent the manufacturer of Playskool toys, Hasbro, Inc. from making false claims about protecting children from microbial infections. Hasbro could no longer claim that toys treated with triclosan protect children from infectious diseases caused by bacteria because it did not prove efficacy to EPA.

2000 The American Medical Association’s Council on Scientific Affairs stated that no data exist to support the efficacy of antimicrobial ingredients when used in such products or any need for them.

2004 Beyond Pesticides publishes The Ubiquitous Triclosan: A common antibacterial agent exposed, first detailing the potential human and environmental dangers associated with its use.

2005 The FDA’s Nonprescription Drugs Advisory Committee voted 11-1 that antibacterial soaps and washes were no more effective than regular soap and water in fighting infections.

Beyond Pesticides submits the first citizen petition requesting FDA to ban all non-medical uses of triclosan.

Researchers at Virginia Tech report that triclosan can reacts with chlorine in tap water to form significant quantities of chloroform -a probable human carcinogen.

2008 Results from a study by EPA scientists show a dramatic decrease in the thyroid hormone -thyroxine in rats exposed to increasing concentrations of triclosan. This thyroid hormone is critical for normal development and to a properly functioning metabolism, indicating that triclosan exposure significantly impacts thyroid hormone concentration.

A published Swedish study finds triclosan in plasma and breast milk of nursing mothers.

EPA’s registration review for triclosan was completed with EPA finding that the chemical presented no unreasonable risks to human and environmental health. However, based on concerns raised by Beyond Pesticides and others, the agency agreed to review the chemical again in 2013- ten years earlier than required.

2009 CDC’s Fourth National Report on Human Exposure to Environmental Chemicals finds significant levels of triclosan in the urine of 75% of the U.S. population during 2003-2004.

Beyond Pesticides, in partnership with Food and Water Watch and 80 other groups, submitted an amended petition to FDA calling for a ban on the non-medical uses of triclosan.

2010 Soon after the FDA petition was submitted, another was submitted to EPA requesting a ban and citing violations of numerous federal statutes.

Beyond Pesticides launches its grassroots triclosan campaign urging consumers to pledge not to buy triclosan products, pass local policies and educate their communities on the dangers of triclosan’s use.

Rep. Ed Markey (D-MA) submitted letters of concern to both EPA and FDA. In FDA’s response, the agency acknowledged that soaps containing triclosan offer no additional benefit over regular soap and water. FDA stated that “existing data raise valid concerns about the [health] effects of repetitive daily human exposure to these antiseptic ingredients” and announced plans to address the use of triclosan in cosmetics or other products. FDA also expressed concern about the development of antibiotic resistance from using antibacterial products and about triclosan’s potential long-term health effects. EPA responded that the agency will review the chemical in 2013.

A study by U.S. Department of Agriculture (USDA) scientists provides details on fertilizing soils with biosolids and the introduction triclosan into the environment. Results show that triclosan in biosolids is only slowly degraded and persists at low levels in the environment for long periods of time.

Another study showed that triclosan from sewage sludge can be taken up by soybean plants and translocated into the beans themselves.

Updated CDC data reports that levels of triclosan in humans have increased by over 40% since 2004.

A University of Florida, Gainesville study reports that triclosan can interfere with estrogen metabolism in women and can disrupt a vital enzyme during pregnancy.

EPA opens Beyond Pesticides’ petition for public comment. Over 10,000 individuals supported a ban on triclosan.

2011 Colgate-Palmolive states it is reformulating its popular soap products to exclude triclosan.

A study reports that triclosan fails to be effective against bacteria in hospital settings. The study finds the underlying cause of a fatal outbreak of P. aeruginosa in a hospital came from the contamination of triclosan soap dispensers, which acted as a continuous source of the bacterium. The contaminated triclosan soap infected the hands of health care workers and then patients, since triclosan is shown to have no effect on P. aeruginosa -a bacterium frequently associated with hospital-acquired infections.

GlaxoSmithKline announces it will remove triclosan from its Aquafresh and Sensodyne toothpastes, as well as its Corsodyl mouthwash.

2012 The Canadian government declared triclosan toxic to the environment, a move which could see the use of the chemical curtailed sharply in Canada. A toxic designation under the Canadian Environmental Protection Act triggers a process to find ways to curtail a chemical’s use, including a possible ban in a range of personal-care products.

The University of Texas (UT) Student Government body unanimously passed a resolution to ban soap containing triclosan throughout campus.

Scientists at the University of California (UC) Davis, and the University of Colorado find that triclosan hinders muscle contractions at a cellular level, slows swimming in fish, and reduces muscular strength in mice. The authors note that the chemical’s effects are so striking that the study “provides strong evidence that triclosan could have effects on animal and human health at current levels of exposure.”

Johnson and Johnson announced that it will begin phasing out a number of potentially dangerous chemicals from its personal care brands, including triclosan.

2013

The Minnesota Pollution Control Agency announces that state agencies have been ordered by Governor Mark Dayton to stop buying products that contain triclosan.

EPA initiates triclosan’s registration review.

Multinational manufacturer Procter and Gamble (P&G) announces that it will eliminate the harmful antibacterial chemical triclosan from its products by 2014.

FDA announces that it will now require manufacturers to prove that their antibacterial soaps are safe and are more effective than soap and water.

2015

EPA rejects Beyond Pesticides and Food and Water Watch’s petition to ban triclosan but will evaluate and conduct a biological assessment of the potential for effects on listed species under the Endangered Species Act (ESA).

European Union’s European Chemicals Agency (ECHA) finds “[N]o safe use could be demonstrated for the proposed use of Triclosan,” and announced triclosan will be phased-out for hygienic uses and replaced by more suitable alternatives.

New York State Senator Tim Kennedy (D-NY) called for a statewide ban on triclosan,a dn introduces Bill S6070 that would prohibit the sale of cleaning products containing triclosan, triclocarban, or derivatives of similar antibacterial compounds.

2016

FDA announces it will no longer allow triclosan, triclocarban and 17 other antibacterial substances in antibacterial soaps.